1.0 PURPOSE:
To lay down a procedure for retesting of Raw material and packing material.
2.0 SCOPE:
This procedure is applicable to retesting of Raw material and packing material tested at (Company name).
3.0 DEFINITION:
Nil.
4.0 RESPONSIBILITY:
4.1 Warehouse Personnel: Responsible to generate the list of materials due for retest and follow the procedure.
4.2 QC personnel: Responsible for resample and analysis of the materials and follow the procedure.
4.3 Head QC / QA: Responsible for the Implementation and Compliance of the procedure.
5.0 PROCEDURE:
5.1 Retest of Materials:
5.1.1 The warehouse personnel shall generate the “List of materials due for retest in Next 45 days” in every month and monitor the list of materials every-day morning.
5.1.2 If any material is found to be due-for retest within Next 3 working days, Warehouse personnel shall deface the Approved label already available on containers and initiate “Material retest note”.
5.1.3 Warehouse personnel shall affix “Quarantine (Under retesting)” status label on the container nearby to the previously affixed approved label on the packs / containers and transfer the concerned containers to Quarantine area. Forward the dully filled “Material retest note” to QC for subsequent Sampling & Analysis.
5.1.4 The QC personnel’s shall resample the raw material and analyze as per tests mentioned in individual specification.
5.1.5 The QC personnel’s shall resample packing, while retesting the packing materials the QC officer shall perform only those tests mentioned below,
For packing material:
PVC Film: Visual observation and Description
HDPE Container/ Glass Vial: Visual observation and Description
Rubber Stoppers: Visual Observation and Microbiological Tests
Label/Carton: Visual Observation and Description
Shipper: Visual Observation and Bursting strength.
Tertiary packing material (i.e. Metal seal, Bopp Tape, Plain Label, Shrink film etc.): Visual Observation.
5.1.6 Perform the tests as mentioned above whichever applicable for the particular sample by following the respective specifications.
5.1.7 After completion of analysis and review of the results, release the material.
5.1.8 Quality control shall release the material and affix the appropriate status label.
5.2 Expiry of Raw material:
5.2.1 The warehouse personnel shall generate the “List of materials due for Expiry in Next 3 months” in every month and monitor the list of materials every-day morning.
5.2.2 If any material is found to be due-for expiry within Next 7 working days, Warehouse personnel shall deface the approved label on the expired containers and shall transfer the said container to the Rejection Room.
5.3 Retesting Frequency:
5.3.1 For Raw material:
5.3.1.1 API shall be retested once in 12 months. Excipients shall be retested once in 24 months.
5.3.2 For Packing material:
5.3.2.1 Vial, Rubber stopper, Label, and Secondary packing material (Printed label, Printed packing material) shall be retested once in 24 months.
Note: Retest period shall be followed as mentioned in Individual specifications, wherever retest period is not specified in individual specification above specified retest period shall be considered.
6.0 ABBREVIATIONS:
API : Active pharmaceutical Ingredient
SOP : Standard Operating procedure
HDPE : High density poly ethylene
7.0 REFERENCES:
Nil.
8.0 LIST OF ANNEXURES:
Nil.